Rapid deployment prosthetic heart valve

• US 8,500,798 B2
• Filed: 05/24/2006
• Issued: 08/06/2013
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Wood, Larry, Bourang, Henry, Bakis, George, Spenser, Benjamin, Benichou, Netanel, Keidar, Yaron, Bash, Assaf
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/441,406
• Publication Number:
  US 20060287719A1
• Time in Patent Office: 2,631 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623/2.14, 623/2.4, 623/2.41, 623/2.38
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Claims

1. A two-stage prosthetic heart valve, comprising:

an expandable anchoring member having opposed ends and an open channel therethrough, and sized to contact a heart valve annulus in an expanded state;

a non-expandable valve member having a suture-permeable sewing ring on an inflow end configured for connection to the anchoring member, the valve member having a plurality of commissure posts extending in an outflow direction that support flexible leaflets comprising animal tissue therebetween, the sewing ring being sized to seat against or within a first end of the anchoring member; and

at least one coupling member attached to the anchoring member and extending from the first end thereof over the commissure posts of the valve member so as to secure the valve member to the anchoring member.

2. The heart valve of claim 1, wherein the coupling member is configured to change shape from a first configuration to a second configuration that wraps over the commis sure posts.

3. The heart valve of claim 2, wherein the coupling member is formed of a malleable material that can be bent from the first configuration to the second configuration.

4. The heart valve of claim 2, wherein the coupling member is hinged and can be pivoted from the first configuration to the second configuration.

5. The heart valve of claim 2, wherein the coupling member is formed of a shape memory material that curls from the first configuration to the second configuration upon being implanted in the body.

6. The heart valve of claim 1, wherein the anchoring member comprises a generally tubular stent with an outflow portion having a larger diameter than an inflow portion, and wherein the sewing ring is sized to fit within the outflow end of the stent.

7. The heart valve of claim 6, wherein the stent forms a ridge between the outflow and inflow portions that provides a seat for the sewing ring of the valve member.

8. The heart valve of claim 7, wherein the ridge incorporates a radiopaque support wire.

9. The heart valve of claim 1, wherein the coupling member comprises a wireform-shaped member with cusps and commissures that closely surrounds and conforms to the cusps and commissures of the valve member, wherein the wireform-shaped member cusps attach to the anchoring member and the wireform-shaped member includes a plurality of commissure tabs that extend over each of the commissure posts of the valve member.

10. The heart valve of claim 9, further including securing tabs on the wireform-shaped member cusps which pierce the sewing ring and attach to the anchoring member.

11. The heart valve of claim 9, further including a plurality of securing tabs placed generally continuously around the wireform-shaped member and providing generally uniform contact with the valve member.

12. A two-stage prosthetic heart valve, comprising:

an expandable anchoring member having opposed ends and an open channel therethrough, and sized to contact a heart valve annulus in an expanded state;

a non-expandable valve member having a base ring on an inflow end and plurality of commissure posts extending in an outflow direction that support flexible leaflets comprising animal tissue therebetween, the base ring being sized to seat against or within a first end of the anchoring member; and

a plurality of coupling posts attached to the anchoring member and extending from the first end thereof, one over each of the commissure posts of the valve member, so as to secure the valve member to the anchoring member.

13. The heart valve of claim 12, wherein each coupling post is configured to change shape from a first configuration to a second configuration that wraps over the commissure posts.

14. The heart valve of claim 13, wherein each coupling post is formed of a malleable material that can be bent from the first configuration to the second configuration.

15. The heart valve of claim 13, wherein each coupling post is hinged and can be pivoted from the first configuration to the second configuration.

16. The heart valve of claim 13, wherein each coupling post is formed of a shape memory material that curls from the first configuration to the second configuration upon being implanted in the body.

17. The heart valve of claim 12, wherein the anchoring member comprises a generally tubular stent with an outflow portion having a larger diameter than an inflow portion, and wherein the base ring is sized to fit within the outflow end of the stent.

18. The heart valve of claim 17, wherein the stent forms a ridge between the outflow and inflow portions that provides a seat for the base ring of the valve member.

19. The heart valve of claim 18, wherein the ridge incorporates a radiopaque support wire.

20. The heart valve of claim 12, wherein the coupling posts are each formed with a recess for receiving the tips of the commissure posts in a snap-fit relationship.

21. A system for retrofitting a conventional prosthetic heart valve, comprising:

an off-the-shelf, non-expandable prosthetic heart valve having a sewing ring on an inflow end capable of being implanted using sutures through the sewing ring in an open-heart procedure, the heart valve having a plurality of commissure posts extending in an outflow direction that support flexible leaflets comprising animal tissue therebetween;

an expandable anchoring member having opposed ends and an open channel therethrough, and sized to contact and anchor to a heart valve annulus in an expanded state, a first end of the anchoring member being sized to seat against or around the sewing ring; and

coupling means for connecting the prosthetic heart valve to the anchoring member, the prosthetic heart valve thus being attached to the heart valve annulus via the anchoring member, the coupling means being attached to the anchoring member and extending from the first end thereof over the commissure posts of the heart valve so as to secure the heart valve to the anchoring member.

22. The system of claim 21, wherein the coupling means is configured to change shape from a first configuration to a second configuration that wraps over the commissure posts.

23. The system of claim 22, wherein the coupling means is formed of a malleable material that can be bent from the first configuration to the second configuration.

24. The system of claim 22, wherein the coupling means is hinged and can be pivoted from the first configuration to the second configuration.

25. The system of claim 22, wherein the coupling means is formed of a shape memory material that curls from the first configuration to the second configuration upon being implanted in the body.

26. The system of claim 21, wherein the anchoring member comprises a generally tubular stent with an outflow portion having a larger diameter than an inflow portion, and wherein the sewing ring is sized to fit within the outflow end of the stent.

27. The system of claim 26, wherein the stent forms a ridge between the outflow and inflow portions that provides a seat for the sewing ring of the heart valve.

28. The system of claim 27, wherein the ridge incorporates a radiopaque support wire.

29. The system of claim 21, wherein the coupling means comprises a wireform-shaped member with cusps and commissures that closely surrounds and conforms to the cusps and commissures of the heart valve, wherein the wireform-shaped member cusps attach to the anchoring member and the wireform-shaped member includes a plurality of commissure tabs that extend over each of the commissure posts of the heart valve.

30. The system of claim 29, further including securing tabs on the wireform-shaped member cusps which pierce the sewing ring and attach to the anchoring member.

31. The heart valve of claim 29, further including a plurality of securing tabs placed generally continuously around the wireform-shaped member and providing generally uniform contact with the valve member.